The purpose of this funding opportunity announcement (FOA)
is to stimulate innovation and development of technologies and reagents that
will accelerate the discovery of biological biomarkers for Parkinson’s
disease (PD). It is expected that the NINDS Parkinson’s disease biomarkers
program (PDBP) will consolidate, integrate and enhance NINDS-funded PD
biomarkers research projects. This FOA will foster research into biospecimen
preparation methodologies, quantitative analyte analysis, reagent and assay
development, and data analysis methods needed for PD biomarkers progress to
occur. Utilization of extant specimens and data for novel discovery projects
is permitted under this FOA, as long as consent enables deposition of all
data into the PDBP Data Management Resource (DMR).

Key Dates

Posted Date

March 16, 2012

Open Date (Earliest Submission Date)

April 23, 2012

Letter of Intent Due Date

April 23, 2012

Application Due Date(s)

May 23, 2012 , by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

July, 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 30, 2012

Expiration Date

May 24, 2012

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide, except where instructed to do otherwise
(in this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

Recently, there has been considerable progress in our
understanding of the biology of Parkinson’s disease (PD). However, several
factors currently impede therapy development and clinical study design for
neuroprotective agents. These include the limited ability to detect early
stage PD prior to the onset of motor signs, inadequate measures of processes or
pathways related to disease pathogenesis, and the lack of biomarkers that
define disease progression. To overcome these obstacles, the National
Institute of Neurological Disorders and Stroke (NINDS) is establishing a
Parkinson’s Disease Biomarkers Program (PDBP).

The overall purpose of the NINDS PDBP is to rapidly identify
and develop potential biomarkers to improve the efficiency and outcome of Phase
II clinical trials and advance therapeutic development for PD. The NINDS PDBP
will coordinate the efforts of multiple stakeholders interested in the
identification and development of diagnostic, progression or prognostic PD biomarkers
and related assays by: 1) standardizing data and biospecimen collection and
management across new PD cohort studies; 2) enhancing efforts of current PD
biomarker studies through ancillary projects that support additional well
characterized biospecimen collection; 3) accelerating the discovery of new
biomarkers; and 4) fostering and expanding collaborative opportunities for all
stakeholders.

2) Technology-based studies. These could attempt to
identify novel PD biomarkers through the use of genomic, metabolomic, proteomic,
histologic, cellular, or neuro-imaging based platforms or they could attempt to
develop of assays for reliable measurement of single or multiple molecular
analytes that are related to diagnosis, progression or prognosis of PD;

4) Data management through a contract-supported Data
Management Resource (DMR) that will utilize common PDBP clinical data elements
for the standardization and sharing of biomarker-related data (see below).

In collaboration with the PD research community, NINDS will
integrate all of its current and future PD biomarker projects within this
program. We expect this approach to remain flexible in order to adapt to
advances in the field as they occur. Public sharing of data and biospecimens
collected is required under the PDBP.

Scope
of Research

The scope of this FOA is to develop new and/or improved PD
biomarker methodologies and technologies that can help inform Go/NoGo decisions
in phase 2 clinical trials including:

biospecimen preparation methodologies and technologies for the
development of assays to assess sample quality;

quantitative analysis of proteins and peptides that will improve
the technological capability to reliably identify, quantify, and compare
measurements and analyses of proteins and peptides in complex biological
mixtures related to human PD;

data analysis methods necessary for the field of PD biomarkers to
move forward and;

other studies required for moving an assay or method from an
exploratory stage towards a validated approach for PD biomarker assessment.

Applications for the development of resources such as
databases, therapeutic agents, and tissue repositories, or the development of
animal models are not responsive to this FOA. Clinical studies including
clinical trials will not be supported under this FOA. This FOA will not
support studies that develop general methods; all applications must be specific
to Parkinson’s disease research.

Every application should provide justification for project
alignment with the PDBP goals as described above. All applications must also
delineate how the planned discovery project will fill a gap not currently or
previously addressed in other studies in PD research. If an application plans
to utilize the infrastructure or resources of existing projects, whether funded
by the NINDS, other governmental or nongovernmental entities, letters of
support detailing the terms of collaboration and data sharing must be included.
A Data Management Resource, DMR, as outlined below, will be established by the
NINDS for all data management under this program; the development of new
databases will not be supported under this FOA.

Potential applications that would be responsive to this RFA
include but are not limited to:

Sample Preparation and Labeling Technologies – Procedures and/or
reagents used for preparing the sample for optimized PD specific protein
identification, quantification, and validation. Relevant platforms can include
a variety of procedures and resources including storage, proteolytic or other
enzymatic digestion, preparation, and labeling for identification and
quantitative analysis.

Sample Fractionation Technologies – Fractionation schemes for
separating various PD specific protein classes or forms (i.e., glycopeptide
capture, phosphopeptide capture) or separating proteins according to size,
charge, hydrophobicity, or affinity, etc. Technologies and platforms may
include the development of various affinity and capture reagents for future use
in PD biomarkers research.

Mass Spectrometry – Advances in mass spectrometry can include a
broad range of technological developments including increased range of mass to
charge feature representation of PD specific proteins and peptides,
protein/peptide identification quantification, reproducibility, and sample
throughput, but the primary focus should be on improved protein identification
and quantification as it relates to PD biomarkers research.

Imaging or other technologies to identify and track the pathology
of PD or closely related biologic processes. These might include development of
PET ligands for synuclein or dopaminergic terminals, sensitive assays of
worsening autonomic dysfunction, objective clinical measures of disease
progression that are not affected by dopaminergic drugs, MRI techniques to
sensitively track nuclear or white matter degeneration.

Data Analysis – Analytical approaches, algorithms, and ontologies
for PD specific peptide/protein identification and quantification, data
processing, and microsimulation. Computational and data analysis platforms
should focus on the analysis, characterization, and comparison of large PD
human data sets and multi-dimensional data including imaging and genetic
information. Annotation and analytical platforms must be open source and
available for public use.

Statistical
Requirements

All applications must include statistical justification for
the approach. Key personnel with statistical expertise should be identified
for each project in order to assure alignment of the individual study
recruitment goals with the overall goals of the DMR and the PDBP.

Data
Management Resource (DMR)

The PDBP Data Management Resource will provide an essential
data coordination tool for the entire PD biomarker research community through
the development of a web-based data management system that provides tools to
PDBP supported projects for both the collection and quality assurance of data
in a standardized format. The DMR will also coordinate the assembly of
de-identified data into a common database thus enabling the query and
distribution of aggregate data for the acceleration of PD biomarker discovery
and validation. The PDBP data management resource will synchronize efforts
across government and non-government organizations involved in PD biomarker
research through the creation of a federated database. Federation will enable
the owner of the non-DMR dataset to maintain the data sharing/data access
policies of that dataset. A summary and access request to the federated
datasets will be hosted on the NINDS DMR web portal. Data users with access to
other databases will be able to receive a report in response to a data query
that includes aggregated data from all approved sources.

Applications proposing efforts that are duplicative of DMR
functions or responsibilities will not be funded in part or at all. Activities
that are the sole purview of the DMR include: 1) development of standardized
electronic data forms, data formats and software for use across multiple
cohorts and projects; 2) development of software to support subject scheduling,
site tracking, and facilitation and coordination of de-identified clinical and
biospecimen data collection across multiple new and existing cohorts and
projects through an easy to use web-based entry system for submitters; 3)
quality assurance checks of data entry and collection; 4) development of a
user-friendly query system for users to evaluate availability of data and
biospecimens within and across PD biomarker projects; 5) development of
aggregate data report formats that are user-friendly and supported by well
documented data dictionaries; 6) training for both data submitters and data
users; 7) coordination of data and biospecimen summary reports and postings in
collaboration with the NINDS Repository; and 8) public outreach for data
submission and data use. Development of all electronic data entry forms and
quality assurance checks of de-identified data will be done by the DMR. The
study site must identify at the time of application, key personnel whose
responsibility will be to ensure and facilitate data quality, transfer, and sharing
under this program. For those with existing studies already utilizing a data
management core or resource, data will not be required to be entered twice or
transferred, but, must be federated with the DMR. Deposition of all data into
the PDBP DMR should occur in real time.

Application
Requirements

The body of the application must present the relevance of
the proposed measure to PDBP but should not generally review the field of
clinical aspects or biomarkers in PD.

Each Application must include the following:

Milestones: Proposed annual milestones must be included.
Biomarkers research at this stage is inherently high-risk, and so the use of
milestones in these projects will provide clear indicators of a project's
continued success or emergent difficulties. Milestones are goals that create
go/no-go decision points in the project and must include quantitative success
criteria. The milestones will weigh heavily in the peer review process and
poorly-constructed milestones will have a negative effect on impact scores. Achievement
of milestones will be evaluated by NINDS, and funding of non-competing award
years will depend on milestone accomplishment. Milestones should be specific,
quantifiable and scientifically justified; they should not be simply a
restatement of the U18 specific aims. Milestones should be placed at the
end of the Research Strategy section and are included in the 12-page limit.

A discussion of expected results, potential pitfalls, and
alternative approaches.

A plan within the proposed study to establish performance
characteristics that will be important in future clinical trials. These
characteristics could include (if appropriate): the expected variability of
repeated measures in the same subject: variability of the measure in the
relevant population: variability in measurements across multiple sites or
timepoints.

A description of how data created will be useful for other PD
biomarkers researchers.

Statistical Analyses: methods should be proposed that are
appropriately matched to the study design.

Guidance
for Research Tools Sharing Plan and Intellectual Property Plan

Restricted availability of unique research resources, upon
which further studies are dependent, can impede the advancement of research.
The NIH is interested in ensuring that the research resources developed through
this Initiative will become readily available to the broader research community
in a timely manner for further research, development, and application, in the
expectation that this will lead to products and knowledge of benefit to the
public health.

Investigators conducting biomedical research frequently
develop unique research resources. The policy of the NIH is to make available
to the public the results and accomplishments of the activities that it funds.
To ensure that research resources are made accessible to the broader biomedical
community, NIH expects applicants who respond to this funding opportunity to
submit a plan for: (1) sharing the research resources generated through any
grants awarded and (2) addressing how they will exercise intellectual property
rights, should any be generated through an award, while making such research
resources available to the broader scientific community consistent with this
initiative. Therefore, such research resources sharing and intellectual
property management plans would make unique research resources readily
available for research purposes to qualified individuals within the scientific
community in accordance with the NIH Grants Policy Statement (https://grants.nih.gov/grants/policy/)
and the Principles and Guidelines for Recipients of NIH Research Grants and
Contracts on Obtaining and Disseminating Biomedical Research Resources: Final
Notice, December 1999 (”NIH Research Tools Policy” at https://grants.nih.gov/grants/intell-property_64FR72090.pdf).
These documents also: (1) define terms, parties, and responsibilities; (2)
prescribe the order of disposition of rights and a chronology of reporting
requirements; and (3) delineate the basis for and extent of government actions
to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and
are accessible from the Interagency Edison web page (http://www.iedison.gov); see also 35 USC §
210(c); Executive Order 12591, 52 FR 13414 (Apr. 10, 1987); and Memorandum on
Government Patent Policy (Feb. 18, 1983).

If applicants plan to collaborate with third parties, the
research tools sharing plan would need to address how such collaborations would
not restrict their ability to share research materials produced with NIH
funding. The majority of transfers to not-for-profit entities should be
implemented under terms no more restrictive than the Uniform Biological
Materials Transfer Agreement (UBMTA) (http://ott.od.nih.gov/NewPages/UBMTA.pdf).
In particular, recipients are expected to use the Simple Letter Agreement (SLA)
provided at http://ott.od.nih.gov/NewPages/SimplLtrAgr.pdf,
or another document with no more restrictive terms, to readily transfer
unpatented tools developed with NIH funds to other recipients for use in
NIH-funded projects. If the materials are patented or licensed to an exclusive
provider, other arrangements may be used, but commercialization option rights,
royalty reach-through rights, or product reach-through rights back to the
provider are inappropriate. Similarly, when for-profit entities are seeking access
to NINDS-funded tools for internal use purposes, recipients should ensure that
the tools are transferred with the fewest encumbrances possible. The Simple
Letter Agreement (SLA) may be expanded for use in transferring tools to
for-profit entities, or simple internal use license agreements with execution
or annual use fees may be appropriate.

Section II. Award Information

Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

NINDS intends to commit $1M in FY 2012, to fund an
estimate of five awards.

Award Budget

Application budgets should not exceed $200,000 direct
costs in any given year, and must reflect actual needs of the proposed
project.

Award Project Period

Scope of the proposed project should determine the project
period. The maximum period is three years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1.
Overview Information, prospective applicants are asked to submit a letter
of intent that includes the following information:

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of Page
Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

For this application, the following must be included:

Milestone
plan: A milestone plan, under separate headings, must be included in the 12
page Research Strategy section of the application (not Appendix).

Data
Sharing Plan:A
data sharing plan should be included in the body of the application (not Appendix).
Deposition of all data into the PDBP DMR should occur following completion of
data analysis and within one week of publication.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies(GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

The resource Sharing Plan should follow the resource sharing
policy of the PDBP program, which includes deposition of data with the DMR.

The NINDS expects that databases, proteomic standards, and reference
sets developedthroughthe PDBP will be made broadly available to academic and
industry researchers. Through these efforts, the scientific community
will have open and equal access to common reagents and data to facilitate
discovery and cross validation of studies. Applicants should briefly
describe the expected schedule for data sharing, the format of the final
dataset, the documentation to be provided, whether or not any analytic tools
also will be provided.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information
contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following: Studies
responsive to this FOA support the development of technologies or reagents that
will accelerate the discovery of biomarkers for PD. Accordingly, reviewers will
focus their evaluation on the conceptual framework, the level of innovation,
and the potential to significantly advance our knowledge or understanding of PD
biomarkers research.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Is the study proposed important to the
development of technologies or reagents which will be useful in PD biomarkers
discovery?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD(s)/PI(s), do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed? Is a timeline included which delineates clear and feasible milestones? If utilization
of biospecimens or clinical data from an existing project are proposed, do patient
consents allow for the broad sharing of clinical and biological data with the
research community?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NINDS, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Appeals
of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will compete for available funds with all other
recommended applications submitted in response to this FOA. Following initial
peer review, recommended applications will receive a second level of review by
the National Advisory Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Compliance with data sharing policies.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when State and local Governments are eligible to apply), and other HHS, PHS,
and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.

Adhere to existing PDBP study policies regarding data and
biospecimen sharing and other policies that might be established during the
course of this activity;

Report to NINDS Program staff regarding timeline and milestone
achievement during the course of the project, as delineated in the terms and
conditions of award;

Submit annual progress reports during the funding period, in a
format as agreed upon by NINDS program staff;

Accept and implement any other common guidelines and procedures
developed for the PDBP initiative and approved by NINDS program staff;

coordinate with other projects under the PDBP, including sharing
of data with a centralized data management resource and other PDBP sites;

Attend in-person PDBP meetings up to twice per year organized by
NINDS and present up to date findings (including unpublished results) on
ongoing projects.

Awardees are expected to make new information and materials
known to the research community not only in the bi-annual PDB P meeting but
also in a timely manner through publications, web announcements, reports to
NINDS program staff, and other mechanisms.

Publications

The PD(s)/PI(s) will be responsible for the timely
submission of all abstracts, manuscripts and reviews (co)authored by project
investigators and supported in whole or in part under this Cooperative
Agreement. The PD(s)/PI(s) and Project Leaders are requested to submit
manuscripts to the NIH Project Scientist within two weeks of acceptance for
publication so that an up-to-date summary of program accomplishments can be
maintained. Publications and oral presentations of work conducted under this
Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate
Project Leaders and will require appropriate acknowledgement of NINDS and PDBP
support. Timely publication of major findings is required.

NIH
staff have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:

NINDS program staff will have substantial
scientific/programmatic involvement during the conduct of this activity through
technical assistance, advice and coordination. However, the role of NINDS
Project Scientists will be to facilitate and not to direct the
activities.

The
NINDS Project Scientist will:

Contribute to the adjustment of research protocols, project
milestones or approaches as warranted;

Serve as a liaison between the awardees, the NINDS Advisory
Council and the larger scientific community;

Coordinate the efforts of the awardee with others engaged in PD
research, including other awardees under this FOA and those involved in related
NINDS programs;

Serve on subcommittees of the PDBP External Liaison Group as
appropriate;

Assist in promoting the availability of data and resources
developed in the course of this project to the scientific community at large;

Assist awardees in the development, if needed, of policies for
dealing with situations that require coordinated action;

Retain the option to recommend the withholding or reduction of
support from any cooperative agreement that either substantially fails to
achieve its goals according to the milestones agreed to at the time of award,
fails to maintain state-of-the-art capabilities, or fails to comply with the
Terms and Conditions of the award including biospecimen and data sharing
requirements.

Areas
of Joint Responsibility include:

None

Other
PDBP Components

Scientific
Liaison Group

The NIH will establish an independent scientific liaison
group (SLG) to assist in determining the broad direction of the PDBP. The SLG
will provide input regarding new research findings and the relevance of that in
the context of funded and proposed projects.

Resource
Acquisition Committee

The Resource Acquisition Committee will evaluate requests
for biospecimens based on transparent criteria for distribution towards PD
biomarkers discovery projects. It is intended that biospecimens be available
for research studies by academics and industry investigators.

Data
Acquisiton Committee

The Data Acquisition committee will assure that data use
requests are compliant with data use policy and procedure requirements prior to
data distribution and monitor any security breaches or other concerns.

Due to the unique requirements of the NINDS PDBP, applicants
are strongly encouraged to consult with NINDS Program Staff early on during the
planning stage of their application (see Agency contacts, Section VIII).
This early contact will provide an opportunity to clarify the applicant's
understanding of NINDS’ policies and guidelines, including the scope of
projects within the PDBP. These discussions also provide important
information and guidance on how to develop an appropriate timeline and milestone
plan, which are subject to peer review under this program.

Opportunities
for Partnership

Projects involving partnerships with industry, small
businesses or non-government organizations are encouraged under this FOA. The
policy of the NIH is to make available to the public the results and
accomplishments of the activities that it funds. To ensure that research
resources are made accessible to the broader biomedical community, NIH expects
applicants who respond to this funding opportunity to submit a plan for: (1)
sharing the research resources generated through any grants awarded and (2)
addressing how they will exercise intellectual property rights, should any be
generated through an award, while making such research resources available to
the broader scientific community consistent with this initiative. Existing
studies in which databases already exist or have been created via other
resources may be maintained under those projects, but not funded via this
program. However, it is expected that these databases will become federated
under the DMR.

Dispute
Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov
on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.